Safety and efficacy evaluation of 3D biodressing containing mesenchymal cells in patients with complex wounds

• Grant number: 21/03817-4
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: December 01, 2021
• End date: November 30, 2023
• Field of knowledge: Health Sciences - Medicine
• Agreement: FINEP - TECNOVA II Program
• Principal Investigator: Carolina Caliári Oliveira
• Grantee: Carolina Caliári Oliveira
• Company: In Situ Terapia Celular Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: Ribeirão Preto
• Associated researchers: Adriana Oliveira Manfiolli ; Maria Carolina de Oliveira Rodrigues ; Maristela Delgado Orellana
• Associated research grant: 16/16013-2 - Cell therapy process otimization for wound healing treatment in patients: biodressing development and evaluation of therapeutic potential of keratinocytes, fibroblasts and mesenchymal cells in chronic ulcers and severe burns, AP.PIPE
• Associated research grant(s): 21/08526-8 - Safety and efficacy evaluation of 3D biodressing containing mesenchymal cells in patients with complex wounds, AP.PIPE

Abstract

Skin ulcers, such as those in patients with sickle cell anemia and extensive skin burns, are associated with several complications, such as infections, loss of water and electrolytes, in addition to pain and functional and aesthetic damage. In addition to epithelial loss, these wounds include local and systemic inflammation and vascular involvement. Currently available treatment approaches lack efficacy. Studies with animal models of extensive burns show benefits of the association of biomembrane with mesenchymal cells in accelerating healing, reducing inflammation and increasing animal survival. Strategies of tissue engineering and three-dimensional bio-printing (3D) create reproducible three-dimensional cellular structures, ensuring not only maintenance of the therapeutic potential of the cells, but also less invasive administration to patients and safety of the cell therapy process. The current research aims to evaluate the therapeutic potential of 3D biodressing, built in 3D bioprinters, containing umbilical cord mesenchymal cells associated with alginate hydrogel, in the healing of complex wounds. These 3D biodressing will be applied on the donor areas of skin autografts in burned patients or on wounds of patients with sickle cell anemia. This research seeks, in an unprecedented way and fully developed in Brazil, to benefit patients with ulcers that are difficult to heal spontaneously. The results of the study may benefit SUS patients with chronic ulcers, whose socio-economic cost is relevant in our country. Cell therapy using 3D biodressing may be used in the future as an alternative treatment for these patients, improving their prognosis and quality of life and minimizing the burden on health systems. In addition, the 3D biodressing is a national technology, which can facilitate the access of Brazilians to cell therapy. (AU)